Xpert® bladder Cancer monitor urine test for non-muscle-invasive bladder cancer surveillance: a prospective clinical trial.

Cystoscopy and urinary cytology are the gold standard tools for monitoring non-muscle-invasive bladder cancer (NMIBC). A new biomarker-based test (Xpert® Bladder Cancer Monitor) has been developed to be used as a non-invasive aid to monitor bladder cancer recurrence in patients with NMIBC. To evaluate the diagnostic performance of the Xpert® Bladder Cancer Monitor test for monitoring patients with NMIBC. In this prospective, non-interventional, monocentric, blinded study, 304 follow-up visits were performed (corresponding to 193 patients) over a period of 18 months. Cystoscopy and cytology or Xpert® Bladder Cancer Monitor test were performed as part of the NMIBC surveillance. During the study period, histologically proven NMIBC recurrence was detected in 24 cases out of 221 tested, among whom 20 had a positive Xpert® Bladder Cancer Monitor test and 8 had positive urine cytology. The Xpert® Bladder Cancer Monitor test sensitivity was significantly higher than that of cytology (83.3% vs 33.3%; p = 0.0015 with continuity correction). The positive and negative predictive values of the Xpert® Bladder Cancer Monitor test were 27.78% [95% confidence interval (CI): 17.43%-38.12%] and 97.32% (95% CI: 94.72%-99.91%), respectively. The Xpert® Bladder Cancer Monitor test is a reliable and sensitive tool for monitoring patients with NMIBC. It performs better than urine cytology with higher sensitivity, and it appears to be more effective in detecting low- and high-grade NMIBC.